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Efficacy of Smoking Cessation Intervention for Head and Neck Cancer Patients

Primary Purpose

Smoking, Head and Neck Neoplasms

Status
Unknown status
Phase
Not Applicable
Locations
Lebanon
Study Type
Interventional
Intervention
Smoking cessation Intervention
Usual care
Sponsored by
Saint-Joseph University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Smoking focused on measuring Smoking cessation, Intervention, Head and Neck neoplasms, Cognitive therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Head and Neck cancer
  • Patients hospitalised from biopsy or surgery
  • Current smokers = smokers in the past 3 months
  • Reachable by phone

Exclusion Criteria:

  • Nonsmokers in the past 3 months
  • Current drug dependance
  • Pregnant women
  • Psychiatric conditions
  • Patients under current smoking cessation intervention

Sites / Locations

  • Saint-Joseph university
  • Hôtel-Dieu De France University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Smoking cessation Intervention

Usual care

Arm Description

Standardised counseling session + motivational gadget + Nicotine replacement therapy (NRT)

A 10-second brief advice to quit smoking

Outcomes

Primary Outcome Measures

7-day point prevalence abstinence
The patient is considered abstinent if he reported not smoking for at least 7 days before the interview

Secondary Outcome Measures

continuous abstinence
continuous abstinence from smoking at the time of follow-up, since the quit date

Full Information

First Posted
December 10, 2015
Last Updated
December 20, 2018
Sponsor
Saint-Joseph University
Collaborators
Hotel Dieu de France Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03786172
Brief Title
Efficacy of Smoking Cessation Intervention for Head and Neck Cancer Patients
Official Title
Smoking Cessation Intervention for Head and Neck Cancer Patients: A Prospective Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Saint-Joseph University
Collaborators
Hotel Dieu de France Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine whether a brief smoking ENT-resident-based intervention increased smoking cessation in patients with Head and Neck cancer attending a Lebanese university hospital, as compared with usual care.
Detailed Description
The primary objective of the study is to evaluate the effectiveness of a brief smoking physician-based intervention on smoking-cessation rates in Head and Neck cancer adult patients. The secondary objective is to assess predictors of long-term smoking cessation in such patients. After an initial assessment of demographic, clinical and smoking characteristics, the patients are randomised (based on a computer randomisation program) in 2 groups: Group 1 will receive the usual care in Lebanon, which consists of a brief advice to quit (10 seconds) Group 2 will receive a brief (10-15 minutes) standardised smoking cessation counseling session peri-operatively (immediately before or after surgery), by an ENT residents, based on the 5 "A"'s motivational interviewing model: Ask (screen for tobacco use) Advise (provide a personalised and strong quit message) Assess (evaluate the smoker's willingness and readiness to quit) Assist (provide cessation counseling, pharmacotherapy, self-help guides) Arrange (for followup to prevent relapse, and evaluate cessation progress) A motivational gadget will be distributed to group 2 patients. They will also be offered nicotine replacement therapy (nicotine transdermal patches) for a total of 8 weeks. This will be followed by a telephone boost session after 6 weeks. The follow-up at 3, 6 and 12 months will be done, for the 2 groups, by a person not implicated in either the randomisation or the intervention (single-blind), in person or, if impossible, by telephone.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking, Head and Neck Neoplasms
Keywords
Smoking cessation, Intervention, Head and Neck neoplasms, Cognitive therapy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Smoking cessation Intervention
Arm Type
Experimental
Arm Description
Standardised counseling session + motivational gadget + Nicotine replacement therapy (NRT)
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
A 10-second brief advice to quit smoking
Intervention Type
Behavioral
Intervention Name(s)
Smoking cessation Intervention
Intervention Description
A 10 to 15 minute standardised counseling session performed peri-operatively by an ENT resident, and based on the 5 "A"s motivational interviewing model (Ask, Advise, Assess, Assist, Arrange) A motivational gadget distributed to the patients Nicotine replacement therapy (NRT), consisting of nicotine transdermal patches for 8 weeks, offered to the patients
Intervention Type
Behavioral
Intervention Name(s)
Usual care
Intervention Description
A 10-second brief advice to quit smoking, performed peri-operatively by an ENT resident
Primary Outcome Measure Information:
Title
7-day point prevalence abstinence
Description
The patient is considered abstinent if he reported not smoking for at least 7 days before the interview
Time Frame
12 months
Secondary Outcome Measure Information:
Title
continuous abstinence
Description
continuous abstinence from smoking at the time of follow-up, since the quit date
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Head and Neck cancer Patients hospitalised from biopsy or surgery Current smokers = smokers in the past 3 months Reachable by phone Exclusion Criteria: Nonsmokers in the past 3 months Current drug dependance Pregnant women Psychiatric conditions Patients under current smoking cessation intervention
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Diane Helou, ENT resident
Phone
96171112426
Email
diane_helou@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Nayla Matar, MD ENT
Phone
9613277725
Email
naylamatar@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amine Haddad, MD ENT
Organizational Affiliation
Hotel Dieu de France Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Saint-Joseph university
City
Beirut
ZIP/Postal Code
1104 2020
Country
Lebanon
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maya Samaha, Librarian
Phone
9611421000
Ext
2211
Email
msamaha@usj.edu.lb
First Name & Middle Initial & Last Name & Degree
Diane Helou, ENT resident
Facility Name
Hôtel-Dieu De France University Hospital
City
Beirut
ZIP/Postal Code
961
Country
Lebanon
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Husein Smayli, MD
Phone
96170817106
Email
hussein.smayli@hotmail.com
First Name & Middle Initial & Last Name & Degree
Nayla Matar, MD; PHD
Phone
96103277725

12. IPD Sharing Statement

Citations:
PubMed Identifier
18807274
Citation
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Results Reference
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PubMed Identifier
23715685
Citation
Nayan S, Gupta MK, Strychowsky JE, Sommer DD. Smoking cessation interventions and cessation rates in the oncology population: an updated systematic review and meta-analysis. Otolaryngol Head Neck Surg. 2013 Aug;149(2):200-11. doi: 10.1177/0194599813490886. Epub 2013 May 28.
Results Reference
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PubMed Identifier
17119047
Citation
Duffy SA, Ronis DL, Valenstein M, Lambert MT, Fowler KE, Gregory L, Bishop C, Myers LL, Blow FC, Terrell JE. A tailored smoking, alcohol, and depression intervention for head and neck cancer patients. Cancer Epidemiol Biomarkers Prev. 2006 Nov;15(11):2203-8. doi: 10.1158/1055-9965.EPI-05-0880.
Results Reference
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PubMed Identifier
16097900
Citation
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Results Reference
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PubMed Identifier
12525530
Citation
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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Citation
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Citation
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Citation
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Results Reference
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Efficacy of Smoking Cessation Intervention for Head and Neck Cancer Patients

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